Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CORE 300 Digital Stethoscope

K-Number: K261694 · 2026-07-23

ApplicantEko Health, Inc.
Decision Date2026-07-23
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORE 300 Digital Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Eko Health, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261694. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE 300 Digital Stethoscope?

CORE 300 Digital Stethoscope is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Eko Health, Inc.. The 510(k) number is K261694.

When did CORE 300 Digital Stethoscope receive FDA 510(k) clearance?

CORE 300 Digital Stethoscope received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261694.

Who is the listed applicant for CORE 300 Digital Stethoscope?

The FDA 510(k) record lists Eko Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE 300 Digital Stethoscope?

The FDA product code for CORE 300 Digital Stethoscope is DQD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06155643EKO SENSORA: Detecting Clinically Significant MurmursRECRUITINGNCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITING

Other records listing Eko Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251494Eko Foundation Analysis Software with Transformers (EFAST)K233609CORE 500 Digital StethoscopeK233409Eko Low Ejection Fraction Tool (ELEFT)

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd LabsK252595Stethophone ProSparrow Acoustics, Inc.K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑